Recurrent GliomaNCT04216550
Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas
An observational study of Recurrent Glioma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Glioma
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jun 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are all received anti-angiogenesis drug (Apatinib) in the First Affiliated Hospital of Zhengzhou University.
Who may be able to join
- Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions.
- With measurable or evaluable disease defined by RANO criteria by MRI scan.
- Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- Life expectancy ≥3 months.
- No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.
- No history of serious hypertension disease.
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- Patients have adequate organ function as defined by the following criteria:
- Hemoglobin (HGB) ≥90g/L
- Absolute neutrophil count (ANC) ≥1.5×109/L
- White blood cell (WBC) ≥3.0×109/L
- Platelet count ≥80×109/L
- Alanine aminotransferase(ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis
- Creatinine (Cr) of ≤1.25 UNL or creatinine clearance(Ccr) > 45 ml/min.
- With written informed consent signed voluntarily by patients themselves.
Who cannot join
- Patients with age<18 or >90 years.
- Pregnant or lactating women.
- Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications).
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Factors that could have an effect on oral medication.
- Abnormal Coagulation (international normalized ratio>1.5, prothrombin time>UNL+4s,activated partial thromboplastin time>1.5 UNL), with tendency of bleeding.
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- Currently receive thrombolytic and anticoagulation therapy
- History of pneumorrhagia(CTCAE grade ≥2 ) or other parts hemorrhage(CTCAE grade ≥3 ) within 4 weeks prior to treatment.
- History of artery thrombosis and phlebothrombosis, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 6 month prior to treatment.
- Medical history of clinically significant thrombosis (bleeding or clotting disorder), excluding warfarin(1mg po qd) and aspirin(80-100mg po qd) for prevention under INR≤1.5.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhenyu Zhang, Dr., +86 17839973727, fcczhangzy1@zzu.edu.cn
About this study
Official title: MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas.
Read the detailed description
Effective treatment for recurrent gliomas is still challenging. Malignant gliomas are considered to be one of the most angiogenic cancers and are mostly sustained by vascular endothelial growth factor (VEGF) signaling via its endothelial tyrosine kinase receptor VEGF receptor 2 (VEGFR-2). Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits VEGFR-2. Apatinib has been demonstrated as monotherapy that prolongs OS in patients with gastric cancers after two or more lines of chemotherapy with moderate, reversible, and easily managed adverse effects. This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study also seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas. The creation of a registry for patients with recurrent gliomas treated by Apatinib with detailed survival data, radiological data, histopathology image data and with sufficient sample size for artificial intelligence provides opportunities for personalized prediction of responses to Apatinib.
- Conditions
- Recurrent Glioma
- Being tested
- Apatinib
- Keywords
- Therapeutic responses, Radiological, Histopathology Imaging, Artificial intelligence, Apatinib
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Response to Treatment
Response were evaluated with Response Assessment in Neuro-Oncology (RANO) criteria every 1 month after treament.
Measured: From enrollment to progression of disease. Estimated about 6 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
Measured: From enrollment to progression of disease. Estimated about 6 months.
Overall Survival (OS)
The length of time from enrollment until the time of death (OS, overall survival)
Measured: From enrollment to death of patients. Estimated about 1 year.
Incidence of treatment-related adverse events
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Measured: Time Frame: 0 to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GliomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216550
- Sponsor's protocol ID
- GliomaAI-5
- Status last verified
- Feb 2021
- First submitted
- 31 Dec 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR and Histopathology Images Based Prediction of Therapeutic Response of Apatinib in Recurrent Gliomas Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04216550
- Acronym / sponsor ID
- GliomaAI-5
- Conditions
- Recurrent Glioma
- Keywords
- Therapeutic responses, Radiological, Histopathology Imaging, Artificial intelligence, Apatinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas.
Detailed description
Effective treatment for recurrent gliomas is still challenging. Malignant gliomas are considered to be one of the most angiogenic cancers and are mostly sustained by vascular endothelial growth factor (VEGF) signaling via its endothelial tyrosine kinase receptor VEGF receptor 2 (VEGFR-2). Apatinib, also known as YN968D1, is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits VEGFR-2. Apatinib has been demonstrated as monotherapy that prolongs OS in patients with gastric cancers after two or more lines of chemotherapy with moderate, reversible, and easily managed adverse effects. This study aims to collect clinical, radiological and histopathology imaging including detailed radiological data, survival data, clinical parameters, molecular pathology and images of HE slices in patients with recurrent gliomas whose are treated with Apatinib, for evaluating the efficacy and safety of Apatinib. Moreover, by leveraging artificial intelligence, this study also seeks to construct and refine MR and histopathology imaging based algorithms that are able to predict the responses to Apatinib of patients with recurrent gliomas. The creation of a registry for patients with recurrent gliomas treated by Apatinib with detailed survival data, radiological data, histopathology image data and with sufficient sample size for artificial intelligence provides opportunities for personalized prediction of responses to Apatinib.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib | – | Drug: ApatinibApatinib 0.5g orally daily until the untolerable toxicities, disease progression or death |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are all received anti-angiogenesis drug (Apatinib) in the First Affiliated Hospital of Zhengzhou University.
Key inclusion criteria (14 listed)
- Adult patients with histologically-confirmed WHO Grade II-IV gliomas which have recurrent or progressive conditions.
- With measurable or evaluable disease defined by RANO criteria by MRI scan.
- Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- Life expectancy ≥3 months.
- No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.
Key exclusion criteria (10 listed)
- Patients with age<18 or >90 years.
- Pregnant or lactating women.
- Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications).
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Factors that could have an effect on oral medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibApatinib 0.5g orally daily until the untolerable toxicities, disease progression or death | Drug | Apatinib |
Primary outcome
Changes of Response to Treatment
Time frame: From enrollment to progression of disease. Estimated about 6 months
Response were evaluated with Response Assessment in Neuro-Oncology (RANO) criteria every 1 month after treament.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment to progression of disease. Estimated about 6 months.
Overall Survival (OS)
Time frame: From enrollment to death of patients. Estimated about 1 year.
Incidence of treatment-related adverse events
Time frame: Time Frame: 0 to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Glioma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Zhang, Dr. (+86 17839973727, fcczhangzy1@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Response to Treatment (time frame: From enrollment to progression of disease. Estimated about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.